The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex

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Morristown,
New Jersey07962

Purpose:

To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal
photopheresis) in the Treatment of AIDS-Related Complex (ARC).

Study summary:

Treatment involves the patient ingesting 8-methoxsalen (8-MOP) by mouth approximately two
hours prior to each photopheresis session. The photopheresis instrument will separate the
patient's white blood cells and some plasma from other blood components and return the
majority of blood components to the patient. The separated white blood cells and plasma will
be exposed to UVA (Ultraviolet A) light while outside the body. The UVA light
photoactivates the 8-MOP drug which is now located in the DNA of the collected cells. After
this exposure, the patients photoactivated white blood cells will be returned to the patient
by venous access.

Criteria:

Inclusion Criteria
Patients must have the following:
- Diagnosis of AIDS-related complex (ARC).
- Veins that can provide adequate access.
- Negative drug screen for drugs of abuse and zidovudine (AZT).
- Be willing to adhere to the protocol and sign a patient informed consent prior to
study entry.
- Live within adequate commuting distance to the treatment center.
- Not be on any other investigational drug/device.
- Be 18 - 80 years old but minimum age requirements may be affected by state
regulations or specific medical conditions.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment
phase.
- Photosensitive disease, such as porphyria or systemic lupus erythematosus. Care must
be taken in selecting patients who require drugs (either systemically or topically)
during the course of the study with photosensitizing potential such as
phenothiazines, tetracyclines, sulfonamides or chlorothiazide.
- Renal insufficiency with creatinine > 3 mg/dl.
- Symptoms of toxic effects (World Health Organization Criteria) resulting from
previous therapy.
- Severe emotional, behavioral or psychiatric problems that in the opinion of the
investigator would result in poor compliance with the treatment regimen.
- Idiosyncratic or hypersensitivity reactions to 8-MOP compounds.
- History of or active Pneumocystis carinii pneumonia, other opportunistic infection or
neoplasms (Kaposi's sarcoma), or wasting syndrome.
- Active hepatitis.
- Aphakia because of the significantly increased risk of retinal damage due to absence
of lenses.
Concurrent Medication:
Excluded:
- Zidovudine (AZT).
- Photosensitizing drugs should not be administered prior to photopheresis treatment.
- Other investigational drugs.
Concurrent Treatment:
Excluded:
- Other treatment using an investigational device.
Patients with the following are excluded:
- Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment
phase.
- Photosensitive disease.
- Symptoms of toxic effects (World Health Organization Criteria) resulting from
previous therapy.
- Severe emotional, behavioral or psychiatric problems that in the opinion of the
investigator would result in poor compliance with the treatment regimen.
- Idiosyncratic or hypersensitivity reactions to 8-MOP compounds.
- Actively involved in drug abuse.
- Aphakia because of the significantly increased risk of retinal damage due to absence
of lenses.
Prior Medication:
Excluded:
- Zidovudine (AZT).
Actively involved in drug abuse.

NCT ID:

NCT00002011

Primary Contact:

N/A

Backup Contact:

N/A

Location Contact:

Morristown, New Jersey 07962United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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